Georg Nickenig1, Rodrigo Estevez-Loureiro2, Olaf Franzen3, Corrado Tamburino4, Marc Vanderheyden5, Thomas F Lüscher6, Neil Moat7, Susanna Price8, Gianni Dall'Ara2, Reidar Winter9, Roberto Corti6, Carmelo Grasso4, Thomas M Snow2, Raban Jeger10, Stefan Blankenberg11, Magnus Settergren9, Klaus Tiroch12, Jan Balzer13, Anna Sonia Petronio14, Heinz-Joachim Büttner15, Federica Ettori16, Horst Sievert17, Maria Giovanna Fiorino18, Marc Claeys19, Gian Paolo Ussia20, Helmut Baumgartner21, Salvatore Scandura4, Farqad Alamgir22, Freidoon Keshavarzi22, Antonio Colombo23, Francesco Maisano24, Henning Ebelt25, Patrizia Aruta4, Edith Lubos11, Björn Plicht26, Robert Schueler1, Michele Pighi2, Carlo Di Mario27. 1. Department of Internal Medicine and Cardiology/Pneumology, University of Bonn, Bonn, Germany. 2. Department of Cardiology, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom. 3. Department of Cardiology, Rigshospitalet, Copenhagen, Denmark. 4. Department of Cardiology, Ferrarotto Hospital, Catania, Italy. 5. Department of Cardiology, OLV Ziekenhuis, Aalst, Belgium. 6. Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland. 7. Cardiac Surgery Department, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom. 8. Intensive Care Unit, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom. 9. Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. 10. Department of Cardiology, University Hospital Basel, Basel, Switzerland. 11. Department of General and Interventional Cardiology, Universitäres Herzzentrum Hamburg, Hamburg, Germany. 12. Department of Cardiology, Helios Klinikum Wuppertal, Wuppertal, Germany. 13. Department of Cardiology, Universitätsklinikum Düsseldorf, Düsseldorf, Germany. 14. Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. 15. Department of Cardiology and Angiology II, Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany. 16. Cardiothoracic Department, Spedali Civili Brescia, Brescia, Italy. 17. Department of Cardiology and Vascular Medicine, CardioVasculäres Centrum Frankfurt, Frankfurt, Germany. 18. Department of Cardiology, Ospedale Civico ARNAS, Palermo, Italy. 19. Department of Cardiology, University Hospital Antwerpen, Edegem, Belgium. 20. Department of Cardiology, Policlinico Tor Vergata, Roma, Italy. 21. Department of Cardiology and Angiology, Universitätsklinikum Münster, Münster, Germany. 22. Department of Cardiology, Castle Hill Hospital, Cottingham, United Kingdom. 23. Department of Cardiology, Università degli Studi San Raffaele, Milano, Italy. 24. Department of Cardiovascular Surgery, Università degli Studi San Raffaele, Milano, Italy. 25. Department of Cardiology, Universitätsklinikum Halle/Saale, Halle/Saale, Germany. 26. Department of Cardiology, University Clinic Essen, Essen, Germany. 27. Department of Cardiology, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom. Electronic address: c.dimario@rbht.nhs.uk.
Abstract
BACKGROUND: The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in real-world patients are still limited. OBJECTIVES: The aim of this multinational registry is to present a real-world overview of TMVR use in Europe. METHODS: The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data. RESULTS: A total of 628 patients (mean age 74.2 ± 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 [72.0%]). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 ± 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, p[log-rank] = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation). CONCLUSIONS: This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms.
BACKGROUND: The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in real-world patients are still limited. OBJECTIVES: The aim of this multinational registry is to present a real-world overview of TMVR use in Europe. METHODS: The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data. RESULTS: A total of 628 patients (mean age 74.2 ± 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 [72.0%]). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 ± 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, p[log-rank] = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation). CONCLUSIONS: This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms.
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